Terapia CAR-T y la implementación de centros de producción académica

Abstract

Cancer represents one of the main challenges in terms of health in Spain, implying high morbidity in the population and considerable public expenditure on its treatment. Advances in the understanding of the immune system and developments in biotechnology have allowed the development of much more specific and targeted treatments, such as immunotherapy. Among these treatments is CAR-T therapy (chimeric antigen receptor T-cell therapy), which involves the genetic modification of T lymphocytes to enable them to selectively recognize and eliminate antigens associated with the tumor through their

cytotoxic capacity.

In this bibliographic project, all relevant information available on various digital platforms has been compiled using keywords, with the aim of synthesizing and reflecting the study objectives. These objectives include aspects such as applicability, CAR-T generation, efficacy and safety, commercial CAR-T products, as well as the implementation of CAR-T in academic centers in Spain. The cytotoxic activity of T lymphocytes has served as the model for the development of CAR-T cells, which are genetically modified to express a specific chimeric antigen receptor against a tumor antigen, allowing the T cell to identify it and, through its cytotoxic action, cause lysis of the tumor cell expressing it. The process of obtaining CAR-T cells involves a rigorous procedure starting from the genetic modification of the patient's autologous T cells in a cleanroom, taking care of every detail to preserve the integrity, efficacy, and sterility of the cells. These CAR-T medications are administered in oncohematological diseases as a third-line treatment.

However, great efforts are being made to make this therapy an effective and safe option in earlier

stages of the disease. The Advanced Therapies Approach Plan of the Spanish National Health System

has facilitated and expedited the approval of commercial CAR-T medications shortly after their

approval by the United States Food and Drug Administration (FDA), as well as the implementation of

academic centers to carry out their own CAR-T therapies. This has allowed the approval of ARI-0001

for chronic lymphoblastic leukemia in adults in Spain, with a cost three times lower than the

commercial price, and the authorization of various clinical trials